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The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates

NCT06380556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-04-24

No results posted yet for this study

Summary

This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants.

Conditions

  • Procedural Pain

Interventions

DEVICE

ShotBlocker

The protruding surface of the ShotBlocker was placed on the heel lance procedure site. While applying pressure on the skin through the ShotBlocker, the nurse performed heel lancing with the needle through the opening in the center of the ShotBlocker. During the 10-second waiting phase, the ShotBlocker was kept at the procedure site with the same pressure. Then ShotBlocker was removed from the skin and routine capillary blood collection procedure was performed.

DEVICE

Mechanical vibration

The vibration device was placed on the infant's left extremity in the mid/lateral region just below the knee where the sural nerve passes. The device was secured to the extremity with a gauze bandage. The vibration device was operated for 30 seconds with reference to previous studies. While the vibration continued, the nurse punctured the heel with a needle. Then, the vibration device continued to work in the waiting phase for 10 seconds. The vibration device was removed from the baby's extremity and routine capillary blood collection procedure was performed.

Sponsors & Collaborators

  • Istanbul Medeniyet University

    lead OTHER

Principal Investigators

  • Aynur Aytekin Özdemir, PhD · Istanbul Medeniyet University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
38 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2023-01-30
Completion
2023-07-13

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06380556 on ClinicalTrials.gov